PREGNANCY DRUG TESTS

The purpose of this debate is to demand an independent public inquiry into hormone pregnancy test drugs. In the process there will be complaints about inadequate answers to parliamentary Questions, the failure of the Committee on Safety of Drugs—now called the Committee on Safety of Medicines—to act responsibly, the medical malpractice of some doctors, the refusal of the Department of Health and Social Security to take appropriate action to prevent tragedies, and the role of the manufacturers of these drugs.

The basic facts are that in 1967 the then Committee on Safety of Drugs was contacted by a doctor—Dr. Isabel Gal—who warned it of the possible dangers of HPT drugs and that in the words of the Minister of State,
she had produced prima facie evidence that foetal abnormalities might be associated with the use of hormonal pregnancy testing.
If that were the case, and in view of the gravity of severe congenital abnormality the drugs should have been immediately suspended pending full clearance by the committee. This ought to have been axiomatic and automatic, especially after our experience of the thalidomide tragedy. Instead, hesitancy was compounded by incompetence and, as a result, more than 1,500,000 pregnant women were placed at unnecessary risk by being given these drugs and thousands of children may have been gravely damaged, suffering such dreadful disabilities
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as blindness, deafness, spina bifida and heart and limb defects, as well as cleft palates.

Instead of taking urgent action, the Government did absolutely nothing. The Committee on Safety of Drugs began a belated pilot study only in 1969 and undertook no full study until 1972. This was clearly a leisurely affair, although the suggested link between congenital abnormalities and hormone pregnancy test drugs was eventually found to be supported. It was not until 1975—eight years after the first reports—that an official warning was published by the committee.

In 1967, when the prima facie evidence was produced, the Government should have advised all doctors immediately of the adverse report and asked them to monitor the drugs carefully, and they should have ruled that if the Committee on Safety of Medicines could not confirm or deny such reports within, say, a year, some action would be taken. If the Government had taken action of this kind, much suffering could have been avoided, but unfortunately they failed to do so. One object of the independent inquiry which I seek should be to establish why the Government failed.

How many children were damaged in that period? Nobody knows. The Government have admitted that they do not know either. So a further object of the inquiry should be to ascertain how many children were damaged and exactly what the deformities were. It will not be easy, but nothing worth while ever is. But it is no use the Department saying, as it has done in parliamentary answers, that it is impracticable, because the children are available for examination, as are the parents and the medical records. In other words, despite the difficulties, most of the evidence is available and should not be swept under the bureaucratic out-trays of committees or Governments.

The Government's attitude is curious. They have admitted to me in answer to Questions that the association between HPT drugs and congenital abnormalities was supported by the study published in 1975; they have even admitted that these conclusions were confirmed last year, in 1977. Yet Ministers persist in saying that it has not been proved that the drugs
2004
cause malformations. Instead, they prefer the euphemism that
The study showed only a statisically significant difference between the number of malformed babies born to mothers who have taken the drugs, when compared with controls.
Is not that a memorable phrase—
only a statistically significant difference"?
They might equally say that there is no evidence that cancer kills; there is merely a statistically significant difference between those who have and those who have not got cancer.

It does not matter, apparently, that the studies supported the association between these drugs and abnormalities. It does not matter that the drugs have been withdrawn suddenly by the manufacturers. It does not matter that parents want to present medical evidence and the broken bodies of their children. The Government parrot the phrase:
It has not been proved that the drugs actually cause malformations".
I should like to ask the Minister of State whether he accepts that the studies conclusively prove that HPT drugs sometimes—not necessarily always—cause abnormalities. Does he confirm or deny that?

It is not only the Committee on Safety of Medicines, as it is now called, and the Government who come badly out of this affair and whose role requires investigation. There is evidence that some doctors continued to prescribe these drugs for pregnancy tests even after the official warnings. The reputable medical journal General Practitioner estimated that in 1976—a year after the official warnings, no less than 8,000 prescriptions were issued for hormone pregnancy test drugs for pregnant women. If this is true, it constitutes medical malpractice on a massive scale and must be investigated.

It is also necessary to inquire whether the Government's "yellow warning" system of notifying doctors of possible dangerous drugs is working effectively. I must say that all experience shows that it is clearly not doing so.

In addition to the role of the Committee on Safety of Medicines, the Government and some doctors, it is also imperative to investigate the activities of the manufacturing companies. For
2005
example, it has been reported that a British medical director of Schering Chemicals in Britain—a subsidiary of Schering A.G. of Berlin—urged the withdrawal of the hormone pregnancy test drug Primodos in 1969, but his plea was rejected by the company. In the same year, the author of a survey for the Royal College of General Practitioners also recommended the withdrawal of the drug, but he, too, was turned down. In fact, it was in that year that Schering issued a booklet which said:
An existing pregnancy is unaffected by Primodos".
Thus the stage was set, and garishly illuminated by advertising, for tragedy. I claim only that the balance of probability should be taken into account, whereas the company was dogmatically asserting—against striking authoritative evidence—that these drugs were harmless. The question of who is right and who is wrong cannot be resolved by the evasions of the Government. For far too long they have uncritically accepted the company's interpretation of events and rejected demands for an independent public inquiry. But parents are increasingly concerned, and so are Members of this House. We are all entitled to know what happened, for the sake of the families and for the sake of the future.

The additional benefits from an independent public inquiry are that it would be an extra check on the work of the Committee on Safety of Medicines; it would lead to improvements in the yellow warning system; and, perhaps most important of all, it would illuminate how commercial firms work when situations of this kind arise. It would thus set a precedent which would serve notice on all drug companies that, although the Committee on Safety of Medicines has limited resources, the public interest will be carefully safeguarded by an independent public inquiry in the event of serious adverse reactions to drugs over a period of time.

I urge the Minister to reconsider his decision and to concede a reasoned, reasonable and legitimate demand.

I appreciate and share the concern of my hon. Friend the Member for
2006
Stoke-on-Trent, South (Mr. Ashley) about possible damage to children from hormonal pregnancy testing. I hope that we might be able to return to the subject and debate it more fully in the future. If my hon. Friend succeeds in a ballot again I hope that the fact that he has raised the matter briefly this afternoon will not be regarded as an argument for giving him lower priority. This is a very important subject, in which there is a great deal of interest.

I must correct the impression that the Committee on the Safety of Medicines has definite evidence that hormonal pregnancy diagnosis tests can damage babies. On the whole, the committee can say only that there is a possibility of an association between such tests and an increaased incidence of abnormality.

My hon. Friend asked whether I accept that studies show that hormonal pregnancy testing often causes abnormalities in babies. Until today my answer to that question might have been "Yes". However, today I have been able to get some evidence of testing in this field by the German Research Association. This study was planned in 1963 in response to the thalidomide tragedy in which my hon. Friend played such an outstanding part. It is the most comprehensive investigation ever conducted. It covered nearly 15,000 women, and nearly 8,000 of the tests on those women have been evaluated in the preliminary report.

The results of the study do not provide evidence that hormonal pregnancy tests were harmful. The study shows that many other factors can influence the outcome of pregnancy. For example, women with abnormal babies had had, according to the study, more previous miscarriages, had had more abnormal children and had suffered more frequently from chronic diseases of various kinds. Cigarette smoking was shown to have an unfavourable effect.

Of the 7,870 women covered in the preliminary report, 337 had used hormonal pregnancy test drugs. In a group of this size it would be expected that there would be 5.4 major abnormalities in the births to these women. In fact, it turned out that there were six. There would have been expected to be 74.8 minor abnormalities in babies born to a group of women of this number. In fact, there were 76. Therefore, it is difficult
2007
to connect that piece of evidence with the case that hormonal pregnancy testing damages the foetus.

This is the evidence produced by the German Research Association. We must have regard to it. I do not overlook the complexities of the issues involved. An English study conducted by Sir Cyril Clarke and colleagues, as reported in the British Medical Journal, showed that there was a highly significant increase in the number of congenital abnormalities where the mother's preceding pregnancy had resulted in a spontaneous abortion.

Equally, the German study shows that women who had had previous miscarriages tended to make greater use of the hormonal pregnancy tests. One can well understand that they would be more anxious to know quickly whether they were pregnant. This offers support for the view that the results of the committee's studies on hormonal pregnancy tests may have been due to some other unidentified confusing factor, most likely relating to the reason that the pregnancy test was used.

It may well be that these tests are not conclusive. I am prepared and will remain prepared to consider any other further scientific evidence which will controvert the findings that the German Research Association has subsequently dug up. If I have time, I shall deal with the Committee on Safety of Medicines' test, which is rather more favourable to my hon. Friend but the outcome of which is more widely known than is the new information which has come forward.

My hon. Friend says that there was delay in warning doctors once Isobel Gal's tests were available. Certainly the Committee on Safety of Drugs, as it then was, did not ignore Dr. Gal's findings in 1967, but it felt that further studies should be undertaken because there was criticism of the basis of Dr. Gal's research project.

The committee, which later became the Committee on Safety of Medicines, instituted its own wide-ranging survey of possible adverse effects of the drugs. The study began in 1969 and was enlarged in 1972. Additional staff were added to
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allow a follow-up of the 850 pairs of cases and controls That was a fairly substantial sample. It was not possible to enlarge the study before that date because the Department was not giving the backup to the work of the committee that subsequent wisdom would have required.

One of the good things that has come out of my hon. Friend's pressure is that my Department and I are now considering what extra resources can be devoted to the work of the Medicines Commission and the Committee on Safety of Medicine.

The outcome of the study of 836 pairs of cases and controls was that 93 mothers of abnormal babies had used hormonal pregnancy testing whereas only 55 mothers who had not used that form of testing were found to have abnormal babies. That was, to quote the phrase that slightly irritates my hon. Friend, a "statistically significant indication" that there might be an association between hormonal pregnancy testing and abnormal foetuses, although that is offset to some extent by the German study. This is the trouble in which we find ourselves.

The time for this debate is running out. My hon. Friend criticised the fact that doctors may still be using drugs such as Primodos. They are capable of being used in perfectly safe ways in other cases.

If a public inquiry is to be held, what are the questions that it is supposed to answer? Is it supposed to prove that our system of drugs surveillance in the 1960s was inadequate? If so, the answer can be given now. It is "Yes", and it was demonstrated more clearly by my hon. Friend than by any one else in the case of the thalidomide tragedy. The then Labour Government passed the Medicines Act 1968 as a result of that tragedy.

My hon. Friend asked whether the reaction of the Committee on Safety of Medicines was slow. I confess that I think that it was, but that was because it had to set up a new system under the Medicines Act and because we were probably not backing up the work of the Committee adequately at that stage. We are seeking to put more resources into this work so that it can cover a wider range of studies than it was covering at that time.

2009
My hon. Friend criticised the yellow card warning to doctors. I agree entirely with what he said. We are convinced that the system is not adequate, and that it could be strengthened not only because of Primodos and thalidomide, but because of Eraldin, and we are experimenting with a new system to replace the yellow card warning.

Would the object of a public inquiry be to provide information to parents to allow them to seek compensation? I have considerable sympathy with that idea, but if parents are successfully to seek compensation, they must get medical research done, which I think would provide a causal connection between the application of these tests and the damage that was caused. That connection does not exist at present.

Finally, is the object to provide information more quickly to GPs? I regret that until recently some GPs were still prescribing these medicines—

§It being Four o'clock, the motion for the Adjournment of the House lapsed, without Question put.